Cell therapies in the clinic
Open accessAbstract
Cell therapies have emerged as a promising therapeutic modality with the potential to treat and even cure a diverse array of diseases. Cell therapies offer unique clinical and therapeutic advantages over conventional small molecules and the growing number of biologics. Particularly, living cells can simultaneously and dynamically perform complex biological functions in ways that conventional drugs cannot; cell therapies have expanded the spectrum of available therapeutic options to include key cellular functions and processes. As such, cell therapies are currently one of the most investigated therapeutic modalities in both preclinical and clinical settings, with many products having been approved and many more under active clinical investigation. Here, we highlight the diversity and key advantages of cell therapies and discuss their current clinical advances. In particular, we review 28 globally approved cell therapy products and their clinical use. We also analyze >1700 current active clinical trials of cell therapies, with an emphasis on discussing their therapeutic applications. Finally, we critically discuss the major biological, manufacturing, and regulatory challenges associated with the clinical translation of cell therapies.
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Non-genetically modified cell therapies and their derived extracellular vesicles are particularly promising because of lower regulatory complexity and potential for earlier clinical adoption.
“Among these, non-genetically modified cell therapies and their derived extracellular vesicles (EVs) are particularly promising because of their lower regulatory complexity and potential for earlier clinical adoption (Wang et al., 2021; Bahmani and Ullah, 2022; Thom and Cronin, 2024).”
From Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production (2025) · cites this paper as Wang et al., 2021
The Biological challenges section (page unavailable) describes non-genetically modified cells as a potentially useful alternative to genetic modification in clinical settings. The Regulatory challenges section (page unavailable) discusses approval barriers for cell therapies generally, but does not say that non-genetically modified therapies or their extracellular vesicles have lower regulatory complexity or could be adopted earlier. The retrieved passages do not address extracellular vesicles. (LLM, conf=0.84)
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Cited by
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Viral <scp>vector‐based</scp> gene therapies in the clinic
Zhao, Z., Anselmo, A. C., & Mitragotri, S. (2022) · Bioengineering & Translational Medicine · doi:10.1002/btm2.10258 · Cited by 269 · see citing works
Self-citationManufacturing cell and gene therapies: challenges in clinical translation
Lee, N. K., & Chang, J. W. (2024) · Annals of Laboratory Medicine · doi:10.3343/alm.2023.0382 · Cited by 78 · see citing works
Chiu, Y.-S., Wang, K.-L., & Wu, K.-L. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2025.1644318 · Cited by 17 · see citing works
Advances in adoptive cellular therapy for colorectal cancer: A narrative review
Yi, X., & Hu, W. (2022) · Annals of Translational Medicine · doi:10.21037/atm-22-6196 · Cited by 14 · see citing works
- Authors
- Wang, L. L., Janes, M. E., Kumbhojkar, N., Kapate, N., Clegg, J. R., Prakash, S., Heavey, M. K., Zhao, Z., Anselmo, A. C., & Mitragotri, S.
- Affiliations
- John A. Paulson School of Engineering & Applied Sciences Harvard University Cambridge Massachusetts USA
- Harvard University (US)
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Anselmo, Aaron C.
- Mitragotri, Samir
- ORCID
- Venue
- Bioengineering & Translational Medicine
- Publisher
- Wiley
- Published
- 2021-02-26
- Volume
- 6
- Issue
- 2
- Pages
- e10214-e10214
- ISSN
- 2380-6761 (ISSN-L)
- PMC
- PMC8126820
- OpenAlex
- W3133159755
- Cited by
- 162
- References
- 15
- Citations by year
- 2026: 28 · 2025: 28 · 2024: 41 · 2023: 32 · 2022: 23 · 2021: 9
- FWCI
- 3.18
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Bioengineering & Translational Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- UNC Libraries
- Funders
- National Institutes of Health (1R01HL143806‐01, R35GM137898)
- National Science Foundation
- U.S. Department of Defense (W81XWH‐19‐2‐0011)
- Topics
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Health Sciences › Medicine › Genetics › Mesenchymal stem cell research
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- cell therapy, clinical trials, clinical translation, cell therapy manufacturing, regulatory challenges, therapeutic applications
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